Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle
FDA 510(k) K141485 · Galil Medical , Ltd.
510(k) numberK141485
Submission
- Device name
- Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle
- Applicant
- Galil Medical , Ltd.
Arden Hills, MN, US - Received
- June 5, 2014
- Decision date
- July 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
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| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…NEY · Traditional | 07/09/2020SE |
| K181741 | IceSphere 1.5 CX Cryoablation NeedleGEH · Special | 07/30/2018SE |
| K181153 | ICEfx Cryoablation SystemGEH · Special | 05/15/2018SE |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI…GEH · Traditional | 11/21/2017SE |
| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX LGEH · Special | 10/11/2016SE |
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…GEH · Special | 08/28/2015SE |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1GEH · Special | 03/05/2015SE |
| K140584 | Icerod CX Cryoablation NeedleGEH · Special | 03/31/2014SE |
| K123865 | Visual-Ice Cryoablation SystemGEH · Special | 02/06/2013SE |
Questions and answers
When was Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle cleared by the FDA?
Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle (K141485) received a 510(k) decision of Substantially Equivalent on July 2, 2014, 27 days after the submission was received.
What is the product code of K141485?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.